RESUMO
The XVI Post-ECTRIMS meeting was held in Seville on 20 and 21 October 2023, where expert neurologists in multiple sclerosis (MS) summarised the main new developments presented at the ECTRIMS 2023 congress, which took place in Milan from 11 to 13 October. The aim of this article is to summarise the content presented at the Post-ECTRIMS Meeting, in an article in two parts. This second part covers the health of women and elderly MS patients, new trends in the treatment of cognitive impairment, focusing particularly on meditation, neuroeducation and cognitive rehabilitation, and introduces the concept of fatigability, which has been used to a limited extent in MS. The key role of digitalization and artificial intelligence in the theoretically near future is subject to debate, along with the potential these technologies can offer. The most recent research on the various treatment algorithms and their efficacy and safety in the management of the disease is reviewed. Finally, the most relevant data for cladribine and evobrutinib are presented, as well as future therapeutic strategies currently being investigated.
TITLE: XVI Reunión Post-ECTRIMS: revisión de las novedades presentadas en el Congreso ECTRIMS 2023 (II).Los días 20 y 21 de octubre se celebró en Sevilla la XVI edición de la reunión Post-ECTRIMS, en la que neurólogos expertos en esclerosis múltiple (EM) resumieron las principales novedades presentadas en el congreso del ECTRIMS 2023, celebrado en Milán del 11 al 13 de octubre. El objetivo de este artículo es sintetizar las ponencias que tuvieron lugar en la reunión Post-ECTRIMS en un artículo desglosado en dos partes. En esta segunda parte se abordan la salud de la mujer y del paciente mayor con EM, las nuevas tendencias en el tratamiento del deterioro cognitivo, con especial mención a la meditación, la neuroeducación y la rehabilitación cognitiva, y se introduce el concepto de fatigabilidad, poco utilizado en la EM. El papel clave de la digitalización y la inteligencia artificial en un futuro teóricamente cercano es objeto de debate, junto con las expectativas que pueden ofrecer. Se repasa la investigación más reciente sobre los distintos algoritmos de tratamiento, y su eficacia y seguridad en el manejo de la enfermedad. Por último, se exponen los datos más relevantes sobre la cladribina y el evobrutinib, y se presentan las futuras estrategias terapéuticas actualmente en investigación.
Assuntos
Congressos como Assunto , Esclerose Múltipla , Idoso , Feminino , Humanos , Masculino , Esclerose Múltipla/terapiaRESUMO
The XVI Post-ECTRIMS meeting took place in Seville on 20 and 21 October 2023. This meeting was attended by neurologists specialising in multiple sclerosis (MS) from Spain, who shared a summary of the most interesting innovations at the ECTRIMS congress, which had taken place in Milan the previous week. The aim of this article is to summarise new developments related to the pathogenesis, diagnosis and prognosis of MS. The contributions of innate immunity and central nervous system resident cells, including macrophages and microglia in MS pathophysiology and as therapeutic targets were discussed. Compartmentalised intrathecal inflammation was recognised as central to understanding the progression of MS, and the relationship between inflammatory infiltrates and disease progression was highlighted. Perspectives in demyelinating pathologies were reviewed, focusing on neuromyelitis optica and myelin oligodendrocyte glycoprotein antibody-associated disease, highlighting their pathophysiological and diagnostic differences compared to MS. Advances in neuroimaging were also discussed, and especially the analysis of active chronic lesions, such as paramagnetic rim lesions. In the absence of clinical improvements in trials of remyelinating treatments, methodological strategies to optimise the design of future studies were proposed. Breakthroughs in detecting the prodromal phase of MS, the use of biomarkers in body fluids to assess activity, progression and treatment response, and research on progression independent of flares were addressed. The need to define criteria for radiologically isolated syndrome and to clarify the concept was also discussed.
TITLE: XVI Reunión Post-ECTRIMS: revisión de las novedades presentadas en el Congreso ECTRIMS 2023 (I).La XVI edición de la reunión Post-ECTRIMS se celebró los días 20 y 21 de octubre de 2023 en Sevilla. Este encuentro reunió a neurólogos especialistas en esclerosis múltiple (EM) de España, quienes compartieron un resumen de las innovaciones más destacables del congreso ECTRIMS, acontecido en Milán la semana anterior. El objetivo de este artículo es sintetizar las novedades relativas a la patogenia, el diagnóstico y el pronóstico de la EM. Se destacaron las contribuciones de la inmunidad innata y las células residentes del sistema nervioso central, incluyendo macrófagos y microglía, en la patofisiología de la EM y como objetivos terapéuticos. La inflamación intratecal compartimentada se reconoció como fundamental para entender la progresión de la EM, y destaca la relación entre infiltrados inflamatorios y la evolución de la enfermedad. Se revisaron perspectivas en patologías desmielinizantes, enfocadas en la neuromielitis óptica y la enfermedad asociada a anticuerpos contra la glucoproteína de mielina de oligodendrocitos, subrayando sus distinciones patofisiológicas y diagnósticas con la EM. También se abordaron los avances en neuroimagen, especialmente en el análisis de las lesiones crónicas activas, como las lesiones con borde paramagnético. Ante la ausencia de mejoras clínicas en ensayos de tratamientos remielinizantes, se propusieron estrategias metodológicas para optimizar el diseño de futuros estudios. Se abordaron los avances en la detección de la fase prodrómica de la EM, el uso de biomarcadores en fluidos corporales para evaluar la actividad, la progresión y la respuesta al tratamiento, y la investigación sobre la progresión independiente de la actividad de brote. Además, se debatió sobre la necesidad de definir criterios para el síndrome radiológico aislado o precisar su concepto.
Assuntos
Esclerose Múltipla , Humanos , Esclerose Múltipla/terapia , Congressos como AssuntoRESUMO
The last consensus statement of the Spanish Society of Neurology's Demyelinating Diseases Study Group on the treatment of multiple sclerosis (MS) was issued in 2016. Although many of the positions taken remain valid, there have been significant changes in the management and treatment of MS, both due to the approval of new drugs with different action mechanisms and due to the evolution of previously fixed concepts. This has enabled new approaches to specific situations such as pregnancy and vaccination, and the inclusion of new variables in clinical decision-making, such as the early use of high-efficacy disease-modifying therapies (DMT), consideration of the patient's perspective, and the use of such novel technologies as remote monitoring. In the light of these changes, this updated consensus statement, developed according to the Delphi method, seeks to reflect the new paradigm in the management of patients with MS, based on the available scientific evidence and the clinical expertise of the participants. The most significant recommendations are that immunomodulatory DMT be started in patients with radiologically isolated syndrome with persistent radiological activity, that patient perspectives be considered, and that the term "lines of therapy" no longer be used in the classification of DMTs (> 90% consensus). Following diagnosis of MS, the first DMT should be selected according to the presence/absence of factors of poor prognosis (whether epidemiological, clinical, radiological, or biomarkers) for the occurrence of new relapses or progression of disability; high-efficacy DMTs may be considered from disease onset.
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Esclerose Múltipla , Neurologia , Humanos , Esclerose Múltipla/tratamento farmacológico , Sociedades , ConsensoRESUMO
INTRODUCTION: On 4 and 5 November 2022, Madrid hosted the 15th edition of the Post-ECTRIMS Meeting, where neurologists specialised in multiple sclerosis outlined the latest developments presented at the 2022 ECTRIMS Congress, held in Amsterdam from 26 to 28 October. AIM: To synthesise the content presented at the 15th edition of the Post-ECTRIMS Meeting, in an article broken down into two parts. DEVELOPMENT: This second part describes the new developments in terms of therapeutic strategies for escalation and de-escalation of disease-modifying therapies (DMT), when and in whom to initiate or switch to highly effective DMT, the definition of therapeutic failure, the possibility of treating radiologically isolated syndrome and the future of personalised treatment and precision medicine. It also considers the efficacy and safety of autologous haematopoietic stem cell transplantation, different approaches in clinical trial design and outcome measures to assess DMT in progressive stages, challenges in the diagnosis and treatment of cognitive impairment, and treatment in special situations (pregnancy, comorbidity and the elderly). In addition, results from some of the latest studies with oral cladribine and evobrutinib presented at ECTRIMS 2022 are shown.
TITLE: XV Reunión Post-ECTRIMS: revisión de las novedades presentadas en el Congreso ECTRIMS 2022 (II).Introducción. El 4 y el 5 de noviembre se celebró en Madrid la Reunión Post-ECTRIMS, en la que neurólogos expertos en esclerosis múltiple resumieron las principales novedades presentadas en el congreso de ECTRIMS 2022, celebrado entre el 26 y el 28 de octubre en Ámsterdam. Objetivo. Sintetizar las ponencias que tuvieron lugar en la Reunión Post-ECTRIMS, en un artículo desglosado en dos partes. Desarrollo. En esta segunda parte, se presentan las novedades sobre las estrategias terapéuticas de escalado y desescalado de los tratamientos modificadores de la enfermedad (TME), cuándo y a quién iniciar o cambiar a TME de alta eficacia, la definición de fracaso terapéutico, la posibilidad de tratar el síndrome radiológico asilado, el futuro del tratamiento personalizado y la medicina de precisión, la eficacia y seguridad del autotrasplante de células madre hematopoyéticas, diferentes aproximaciones en el diseño de ensayos clínicos y en las medidas de resultados para evaluar TME en fases progresivas, retos en el diagnóstico y tratamiento del deterioro cognitivo, y tratamiento en situaciones especiales (embarazo, comorbilidad y personas mayores). Además, se muestran los resultados de algunos de los últimos estudios realizados con cladribina oral y evobrutinib presentados en el ECTRIMS 2022.
Assuntos
Disfunção Cognitiva , Transplante de Células-Tronco Hematopoéticas , Esclerose Múltipla , Gravidez , Feminino , Humanos , Idoso , Esclerose Múltipla/tratamento farmacológico , PrevisõesRESUMO
INTRODUCTION: On 4 and 5 November 2022, Madrid hosted the 15th edition of the Post-ECTRIMS Meeting, where neurologists specialised in multiple sclerosis (MS) outlined the most relevant novelties presented at the 2022 ECTRIMS Congress, held in Amsterdam from 26 to 28 October. AIM: To synthesise the content presented at the 15th edition of the Post-ECTRIMS Meeting, in an article broken down into two parts. DEVELOPMENT: In this first part, the initial events involved in the onset of MS, the role played by lymphocytes and the migration of immune system cells into the central nervous system are presented. It describes emerging biomarkers in body fluids and imaging findings that are predictive of disease progression and useful in the differential diagnosis of MS. It also discusses advances in imaging techniques which, together with a better understanding of the agents involved in demyelination and remyelination processes, provide a basis for dealing with remyelination in the clinical setting. Finally, the mechanisms triggering the inflammatory reaction and neurodegeneration involved in MS pathology are reviewed.
TITLE: XV Reunión Post-ECTRIMS: revisión de las novedades presentadas en el Congreso ECTRIMS 2022 (I).Introducción. El 4 y el 5 de noviembre se celebró en Madrid la XV edición de la Reunión Post-ECTRIMS, donde neurólogos expertos en esclerosis múltiple (EM) resumieron las principales novedades presentadas en el congreso de ECTRIMS 2022, celebrado en Ámsterdam entre el 26 y el 28 de octubre. Objetivo. Sintetizar las ponencias que tuvieron lugar en la Reunión Post-ECTRIMS, en un artículo desglosado en dos partes. Desarrollo. En esta primera parte se presentan los primeros eventos involucrados en el inicio de la EM, la implicación de los linfocitos y la migración de células del sistema inmunitario hacia el sistema nervioso central. Se describen los biomarcadores emergentes en fluidos corporales y los hallazgos de imagen que permiten predecir la evolución de la enfermedad, y que resultan útiles en el diagnóstico diferencial de la EM. También se exponen los avances en las técnicas de imagen que, junto con un mayor conocimiento de los agentes involucrados en los procesos de desmielinización y remielinización, proporcionan una base para abordar la remielinización en el entorno clínico. Por último, se repasan los mecanismos desencadenantes de la reacción inflamatoria y la neurodegeneración implicados en la patología de la EM.
Assuntos
Esclerose Múltipla , Humanos , Esclerose Múltipla/diagnóstico , Sistema Nervoso Central , Biomarcadores , Inflamação , Progressão da DoençaRESUMO
INTRODUCTION: A subcutaneous (SC) formulation of natalizumab has been recently authorised for multiple sclerosis patients. This study aimed to assess the implications of the new SC formulation, and to compare the annual treatment costs of SC versus intravenous (IV) natalizumab therapy from both the Spanish healthcare system (direct health cost) and the patient (indirect cost) perspectives. METHODS: A patient care pathway map and a cost-minimisation analysis were developed to estimate SC and IV natalizumab annual costs over a 2-year time horizon. Considering the patient care pathway and according to natalizumab experience (IV) or estimation (SC), a national expert panel involving neurologists, pharmacists, and nurses provided information/data regarding resource consumption for drug and patient preparation, administration, and documentation. One hour of observation was applied to the first six (SC) or 12 (IV) doses, and 5 min for successive doses. The Day hospital (infusion suite) facilities at a reference hospital were considered for IV administrations and the first six SC injections. For successive SC injections, either a reference hospital or regional hospital in a consulting room was considered. Productivity time associated with travel (56 min to reference hospital, 24 min to regional hospital) and waiting time pre- and post-treatment (SC 15 min, IV 25 min) were assessed for patients and caregivers (accompanying 20% of SC and 35% of IV administrations). National salaries for healthcare professionals were used for cost estimation (, year 2021). RESULTS: At years 1 and 2, total time and cost savings (excluding drug acquisition cost) per patient, driven by saving on administration and patient and caregiver productivity for SC at a reference hospital versus IV at a reference hospital, were 116 h (a reduction of 54.6%) and 3682.82 (a reduction of 66.2%). In the case of natalizumab SC at a regional hospital, the total time and cost saving were 129 h (a reduction of 60.6%) and 3883.47 (a reduction of 69.8%). CONCLUSIONS: Besides the potential benefits of convenient administration and improving work-life balance, as suggested by the expert panel, natalizumab SC was associated with cost savings for the healthcare system by avoiding drug preparation, reducing administration time, and freeing up infusion suite capacity. Additional cost savings could be derived with regional hospital administration of natalizumab SC by reducing productivity loss.
RESUMO
INTRODUCTION: Neuromyelitis optica spectrum disorders (NMOSD) are immune-mediated inflammatory disorders of the central nervous system involving astrocytes, B lymphocytes, anti-aquaporin 4, and such inflammatory mediators as interleukin-6. Several immunosuppressants are used in their treatment. Tocilizumab, an interleukin-6 receptor antagonist, may be a treatment option. METHOD: We performed an observational, retrospective study analysing parameters of effectiveness (annualised relapse rate, disability, and radiological progression) and safety of tocilizumab in patients with NMOSD in whom previous immunosuppressant treatment had failed. We aimed to evaluate the effectiveness and safety of tocilizumab in clinical practice in patients with NMOSD not responding to other immunosuppressants. RESULTS: Five patients with NMOSD were analysed. Sixty percent of patients were women; mean age at diagnosis was 50±5.3 years and mean progression time was 4.5±3.6 years. Previously administered immunosuppressants were rituximab (in all 5), cyclophosphamide (2), and azathioprine (1). Mean time of exposure to tocilizumab was 2.3±1 years. Mean annualised relapse rate was 1.8±1.3 in the year prior to the introduction of tocilizumab and 0.2±0.4 the year after (P<.05), representing a reduction of 88.9%. CONCLUSIONS: In our experience, tocilizumab is safe and effective in patients with NMOSD showing no response to other immunosuppressants.
Assuntos
Neuromielite Óptica , Anticorpos Monoclonais Humanizados , Feminino , Humanos , Imunossupressores/uso terapêutico , Masculino , Neuromielite Óptica/tratamento farmacológico , Recidiva , Estudos RetrospectivosRESUMO
OBJECTIVE: To describe the profile of patients with multiple sclerosis (MS) treated with fingolimod in Spain and to assess the effectiveness and safety of fingolimod after 4 years of inclusion in the Spanish Gilenya Registry. METHODS: An observational, retrospective/prospective, multicenter case registry, including all patients with relapsing-remitting MS (RRMS) starting treatment with fingolimod in 43 centers in Spain. Analyses were performed in the overall population and in subgroups according to prior disease-modifying therapy (DMT): glatiramer acetate/interferon beta-1 (BRACE), natalizumab, other treatment, or naïve. RESULTS: Six hundred and sixty-six evaluable patients were included (91.1% previously treated with at least one DMT). The mean annualized relapse rate (ARR) prior to fingolimod was 1.12, and the mean EDSS at fingolimod initiation was 3.03. Fingolimod reduced the ARR by 71.4%, 75%, 75.5%, and 80.3%, after 1, 2, 3 and 4 years, respectively (p<0.001). This significant reduction in the ARR continued to be observed in all subgroups. After 4 years, the EDSS showed a minimal deterioration, with the EDSS scores from year 1 to year 4 remaining mostly stable. The percentage of patients without T1 Gd+ lesions progressively increased from 45.6% during the year prior to fingolimod initiation to 88.2% at year 4. The proportion of patients free from new/enlarged T2 lesions after 4 years of fingolimod treatment was 80.3%. This trend in both radiological measures was also observed in the subgroups. Adverse events (AEs) were experienced by up to 41.6% of patients (most commonly: lymphopenia [12.5%] and urinary tract infection [3.7%]). Most AEs were mild in severity, 3.6% of patients had serious AEs. CONCLUSIONS: The patient profile was similar to other observational studies. The results obtained from the long-term use of fingolimod showed that it was effective, regardless of prior DMT, and it had adequate safety results, with a positive benefit-risk balance.
Assuntos
Cloridrato de Fingolimode/uso terapêutico , Imunossupressores/uso terapêutico , Esclerose Múltipla/tratamento farmacológico , Adulto , Feminino , Cloridrato de Fingolimode/efeitos adversos , Humanos , Imunossupressores/efeitos adversos , Linfopenia/etiologia , Masculino , Pessoa de Meia-Idade , Recidiva , Sistema de Registros , Estudos Retrospectivos , Espanha , Resultado do TratamentoRESUMO
INTRODUCTION: In the management of multiple sclerosis (MS) there is still a need to identify biomarkers of disease progression, and clinical and subclinical activity. Among them, determination of neurofilament light chain plasma levels (NfL-PM) has shown a possible correlation with clinical course and assessment of therapeutic response in MS patients. However, the determination of NfL-PM has to overcome several obstacles that hinder its integration into healthcare practice, such as the absence of normalised values and standardised protocols. AIM: This article has two main aims: a) to review the evidence on the usefulness of NfL in clinical practice as biomarkers of neurodegeneration and inflammation in MS, and b) to pool the conclusions from a forum of MS experts gathered to discuss the usefulness and applicability of NfL-PM determination in Spain (EMotion Forum 2020). DEVELOPMENT: NfL-PM seems particularly useful in determining subclinical activity in MS and offers the possibility of identifying populations at risk of developing MS, such as cases of radiologically isolated syndrome. Issues such as the monitoring of induction disease-modifying drugs or the assessment of suboptimal responses for the withdrawal of ineffective disease-modifying drugs should be considered. CONCLUSIONS: The experts agreed on the diagnostic and prognostic potential of NfL-PM determination and that its usefulness in MS can contribute to the general development of the technique.
TITLE: Determinación plasmática de neurofilamentos como biomarcador en la esclerosis múltiple: conclusiones del foro EMotion.Introducción. La identificación de biomarcadores de progresión de la enfermedad y de actividad clínica y subclínica continúa siendo una necesidad en el abordaje de la esclerosis múltiple (EM). Entre ellos, la determinación plasmática de niveles de los neurofilamentos de cadena ligera (NfL-PM) ha mostrado una posible correlación con la evolución clínica y la evaluación de la respuesta terapéutica en los pacientes con EM. Sin embargo, la determinación de NfL-PM afronta diversos obstáculos que dificultan su integración en la práctica asistencial, como la ausencia de valores normalizados y protocolos estandarizados. Objetivo. Este trabajo tiene un doble objetivo: a) revisar la evidencia sobre la utilidad en la práctica clínica de los NfL como biomarcadores de neurodegeneración e inflamación en la EM y b) recoger las conclusiones de un foro de expertos en EM reunidos para debatir sobre la utilidad y aplicabilidad de la determinación de NfL-PM en España (Foro EMotion 2020). Desarrollo. Los NfL-PM parecen particularmente útiles a la hora de determinar la actividad subclínica en la EM y ofrecen la posibilidad de identificar poblaciones con riesgo de desarrollo de EM, como los casos de síndrome radiológico aislado. Se deben considerar aspectos como la monitorización de fármacos modificadores de la enfermedad de inducción o la valoración de respuestas subóptimas para retirar fármacos modificadores de la enfermedad poco eficaces. Conclusiones. Los especialistas coincidieron en el potencial diagnóstico y pronóstico de la determinación de NfL-PM y en que su utilidad en la EM puede contribuir al desarrollo general de la técnica.
Assuntos
Esclerose Múltipla/sangue , Proteínas de Neurofilamentos/sangue , Biomarcadores/sangue , Progressão da Doença , Medicina Baseada em Evidências , Humanos , Inflamação , Imageamento por Ressonância Magnética , Esclerose Múltipla/terapia , Fenótipo , Estudos Prospectivos , Estudos Retrospectivos , Espanha , Resultado do TratamentoRESUMO
INTRODUCTION: The recent availability of SARS-CoV-2 vaccines has raised concerns in certain patient groups, such as those with multiple sclerosis. However, there are currently few publications that provide information on this issue. We pooled the information available on the safety and efficacy of vaccination against SARS-CoV-2 in patients with multiple sclerosis, with and without disease-modifying therapy. DEVELOPMENT: The study consisted in a literature search focused on the types of SARS-CoV-2 vaccines, the current status of their approval, and the data available on the safety and efficacy of vaccines in patients with multiple sclerosis, including the new COVID-19 vaccines. Based on this search, the document has been designed taking into account current evidence and expert recommendations. There are no data on the safety and efficacy of SARS-CoV-2 vaccines in patients with multiple sclerosis. However, evidence does exist to suggest that messenger RNA (mRNA) vaccines against SARS-CoV-2 are as safe in these patients as in other individuals. Some therapies with immunosuppressants might reduce the effectiveness of these vaccines and require the scheduling of their administration, preferably before the start of treatment if possible. CONCLUSION: The data available make it possible to recommend mRNA vaccines against SARS-CoV-2 in patients with multiple sclerosis. In patients on fingolimod, cladribine, alemtuzumab, ocrelizumab and rituximab, vaccination prior to the initiation of medication administration would be recommendable whenever possible.
TITLE: Vacunación frente al SARS-CoV-2 en pacientes con esclerosis múltiple.Introducción. La reciente disponibilidad de vacunas contra el SARS-CoV-2 ha suscitado dudas en determinados colectivos de pacientes, como los que padecen esclerosis múltiple. Sin embargo, en la actualidad hay pocas publicaciones que ofrezcan información en este sentido. Se recopila la información disponible sobre la seguridad y la eficacia de la vacunación contra el SARS-CoV-2 en pacientes con esclerosis múltiple, con y sin tratamiento modificador de la enfermedad. Desarrollo. Búsqueda bibliográfica enfocada en los tipos de vacunas contra el SARS-CoV-2, la situación actual de su aprobación, y los datos disponibles sobre la eficacia y la seguridad de las vacunas en pacientes con esclerosis múltiple, incluidas las nuevas vacunas frente a la COVID-19. A partir de esta búsqueda, se ha diseñado el documento recogiendo la evidencia actual y las recomendaciones de expertos. No existen datos sobre la seguridad y la eficacia de las vacunas contra el SARS-CoV-2 en pacientes con esclerosis múltiple. Sin embargo, los datos disponibles permiten prever que las vacunas de tipo ARN mensajero (ARNm) frente al SARS-CoV-2 son tan seguras en ellos como en el resto de los individuos. Algunos de los tratamientos inmunosupresores podrían reducir la efectividad de las vacunas y requerir la planificación del momento de su administración, preferentemente antes del inicio del tratamiento en caso de ser posible. Conclusión. Los datos disponibles permiten recomendar las vacunas de tipo ARNm frente al SARS-CoV-2 en los pacientes con esclerosis múltiple. En los pacientes con fingolimod, cladribina, alemtuzumab, ocrelizumab y rituximab, sería recomendable la vacunación previa al inicio de la medicación cuando sea posible.
Assuntos
Vacinas contra COVID-19 , COVID-19/prevenção & controle , Imunossupressores/efeitos adversos , Esclerose Múltipla/imunologia , SARS-CoV-2/imunologia , Vacinação , Anticorpos Antivirais/biossíntese , Formação de Anticorpos/efeitos dos fármacos , COVID-19/imunologia , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , Controle de Doenças Transmissíveis/métodos , Humanos , Esquemas de Imunização , Hospedeiro Imunocomprometido , Imunogenicidade da Vacina , Imunossupressores/farmacologia , Imunossupressores/uso terapêutico , Vacinas contra Influenza/administração & dosagem , Máscaras , Esclerose Múltipla/tratamento farmacológico , Vacinação/efeitos adversosRESUMO
INTRODUCTION: The current SARS-CoV-2 pandemic is forcing neurologists to carry out a series of adaptations in the management of multiple sclerosis. Neurologists must weigh up the need to start or continue disease-modifying treatments against the risk of infection, the risk of complications from the infection, and the risk of multiple sclerosis activity. Since this is an unprecedented situation, most decisions are being made on the basis of a theoretical approach and the criteria of each neurologist. AIMS: The aim of this study is conduct a literature search to collect available evidence on the relationship between disease-modifying therapies in multiple sclerosis and SARS-CoV-2 infection. This evidence, together with the experience of the authors in the management of patients with multiple sclerosis during the pandemic, will make it possible to offer some proposals for the treatment and follow-up of patients in this epidemiological context. DEVELOPMENT: After the literature search and our experience in the management of patients, a number of proposals for treatment are established for each drug, which must necessarily be individualised for each patient, since, in these exceptional circumstances, their peculiarities can affect the prognosis. CONCLUSIONS: The neurologist should be aware of current evidence to assess the risk-benefit of starting, maintaining and stopping disease-modifying therapies in multiple sclerosis during the pandemic.
TITLE: Documento EMCAM (Esclerosis Múltiple Comunidad Autónoma de Madrid) para el manejo de pacientes con esclerosis múltiple durante la pandemia de SARS-CoV-2.Introducción. La pandemia actual por el SARS-CoV-2 está obligando a los neurólogos a una serie de adaptaciones en el manejo de la esclerosis múltiple. Los neurólogos deben sopesar la necesidad de iniciar o continuar los tratamientos modificadores de la enfermedad en función del riesgo de infección, del riesgo de complicaciones de la infección y del riesgo de actividad de la esclerosis múltiple. Dado que ésta es una situación sin precedentes, la mayoría de las decisiones se están tomando sobre la base de un abordaje teórico y del criterio de cada neurólogo. Objetivos. Se pretende, a través de una búsqueda bibliográfica, recopilar la evidencia disponible sobre la relación entre tratamientos modificadores de la enfermedad en la esclerosis múltiple y la infección por el SARS-CoV-2. Esta evidencia, junto con la experiencia de los autores en el manejo de pacientes con esclerosis múltiple durante la pandemia, permitirá brindar algunas propuestas de tratamiento y seguimiento de los pacientes en este contexto epidemiológico. Desarrollo. Después de la búsqueda bibliográfica y de nuestra experiencia en el manejo de pacientes, se establecen unas propuestas de tratamiento sobre cada fármaco que necesariamente han de individualizarse para cada paciente, ya que, en esta circunstancia excepcional, sus peculiaridades pueden marcar el pronóstico. Conclusiones. El neurólogo debe tener conocimiento de la evidencia actual para valorar el riesgo-beneficio de iniciar, mantener y suspender los tratamientos modificadores de la enfermedad en la esclerosis múltiple durante la pandemia.
Assuntos
Infecções por Coronavirus/complicações , Gerenciamento Clínico , Imunossupressores , Esclerose Múltipla/tratamento farmacológico , Pneumonia Viral/complicações , Betacoronavirus , COVID-19 , Infecções por Coronavirus/epidemiologia , Tomada de Decisões , Humanos , Imunossupressores/efeitos adversos , Imunossupressores/uso terapêutico , Esclerose Múltipla/complicações , Neurologistas , Pandemias , Pneumonia Viral/epidemiologia , Fatores de Risco , Coronavírus Relacionado à Síndrome Respiratória Aguda Grave , SARS-CoV-2RESUMO
INTRODUCTION: Neuromyelitis optica spectrum disorders (NMOSD) are immune-mediated inflammatory disorders of the central nervous system involving astrocytes, B lymphocytes, anti-aquaporin 4, and such inflammatory mediators as interleukin-6. Several immunosuppressants are used in their treatment. Tocilizumab, an interleukin-6 receptor antagonist, may be a treatment option. METHOD: We performed an observational, retrospective study analysing parameters of effectiveness (annualised relapse rate, disability, and radiological progression) and safety of tocilizumab in patients with NMOSD in whom previous immunosuppressant treatment had failed. We aimed to evaluate the effectiveness and safety of tocilizumab in clinical practice in patients with NMOSD not responding to other immunosuppressants. RESULTS: Five patients with NMOSD were analysed. Sixty percent of patients were women; mean age at diagnosis was 50±5.3 years and mean progression time was 4.5±3.6 years. Previously administered immunosuppressants were rituximab (in all 5), cyclophosphamide (2), and azathioprine (1). Mean time of exposure to tocilizumab was 2.3±1 years. Mean annualised relapse rate was 1.8±1.3 in the year prior to the introduction of tocilizumab and 0.2±0.4 the year after (P <.05), representing a reduction of 88.9%. CONCLUSIONS: In our experience, tocilizumab is safe and effective in patients with NMOSD showing no response to other immunosuppressants.
RESUMO
INTRODUCTION: Fingolimod is a disease modifying therapies, which has showed clinical efficacy and an acceptable safety profile in clinical trials with relapsing-remitting multiple sclerosis (RRMS) patients. AIM: To assess fingolimod effectiveness and safety in patients with RRMS in clinical practice. PATIENTS AND METHODS: We present an interim analysis (July 2015) of MS NEXT, an observational, retrospective and multicenter study. 442 patients were included (mean age: 41 ± 9 years; median baseline EDSS: 3.0; 70% female; 284 previously treated with first-line disease modifying therapies, 139 with natalizumab and 19 without a previous treatment; mean fingolimod treatment duration: 25 ± 9 months) treated with fingolimod from November 2011 and with at least 12 months follow-up. 56 neurology-unit Spanish hospitals enrolled patients. Basal clinical and demographic data were recorded. Relapses, EDSS scores and radiological activity were recorded at baseline and annually. Adverse events were also recorded during the follow-up period. RESULTS: After two years of follow-up: annual relapse rates decreased by 76%, the proportion of relapse-free patients was 67%, of disability progression-free patients confirmed at 3 months was 91%, of relapse and disability progression-free patients was 63%, of radiological activity-free patients was 50%, and the proportion of relapse, disability progression and radiological activity-free patients was 35%. Only 3.9% of patients discontinued fingolimod permanently during the first year of treatment. CONCLUSIONS: In this interim analysis, most of patients treated with fingolimod in clinical practice had a controlled clinical disease activity, stable disability progression and high persistency.
TITLE: Efectividad y seguridad del fingolimod en la practica clinica habitual en pacientes con esclerosis multiple remitente recurrente en España: analisis intermedio del estudio MS NEXT.Introduccion. El fingolimod es un tratamiento modificador de la enfermedad que ha demostrado eficacia y seguridad en ensayos clinicos en pacientes con esclerosis multiple remitente recurrente (EMRR). Objetivo. Evaluar la efectividad y la seguridad del fingolimod en pacientes con EMRR en la practica clinica. Pacientes y metodos. Se presentan los resultados del analisis intermedio (julio de 2015) del MS NEXT, un estudio observacional, multicentrico y retrospectivo. Se incluyo a 442 pacientes (edad media: 41 ± 9 años; escala expandida del estado de discapacidad basal, mediana: 3; 70% mujeres; 284 previamente tratados con tratamientos modificadores de la enfermedad de primera linea, 139 con natalizumab y 19 naive; media de tratamiento con fingolimod: 25 ± 9 meses) tratados con fingolimod a partir de noviembre de 2011 y con al menos 12 meses de seguimiento. Participaron 56 hospitales españoles. Se recogieron datos demograficos y clinicos (basal y anualmente, numero de brotes, puntuacion en la escala expandida del estado de discapacidad y actividad radiologica). Tambien se registraron los efectos adversos durante el seguimiento. Resultados. Tras dos años de tratamiento, la tasa anualizada de brotes se redujo un 76%; el 67% de los pacientes estaba libre de brotes; el 91%, libre de progresion de la discapacidad confirmada a los tres meses; el 63%, libre de brotes y progresion de discapacidad; el 50%, libre de actividad radiologica, y el 35%, libre de brotes, progresion de discapacidad y actividad radiologica. Un 3,9% abandono el fingolimod permanentemente. Conclusiones. En este analisis intermedio, la mayoria de los pacientes tratados con fingolimod en la practica clinica presenta una actividad clinica controlada y una elevada persistencia al tratamiento.